Sosei Heptares, a biopharmaceutical company with operations in Tokyo and Cambridge, is facing a significant shift in its partnership with pharmaceutical giant GSK. GSK announced it would cease the development of the experimental oral drug GSK4381406, which targets the orphan receptor GPR35 and has shown promise in the treatment of gastrointestinal immune diseases such as ulcerative colitis.
This decision comes after a change in the direction of GSK's immunology research and leadership. Recently, Kaivan Khavandi stepped into the role as head of the respiratory/immunology division following John Lepore's departure from the company. The change has led to a strategic pivot away from certain drug development initiatives.
Despite GSK's withdrawal from the project, Sosei Heptares has affirmed its commitment to continue with Phase I studies for GSK4381406. The company is actively exploring strategic alternatives to further the drug's development. Their determination is supported by an independent commercial analysis that projects potential peak sales exceeding $3 billion due to the drug's unique target product profile.
The initial agreement between Sosei Heptares and GSK, established in 2020, included financial commitments that could reach up to £370 million ($465 million). This arrangement encompassed an upfront payment along with additional funds contingent upon achieving certain milestones. Earlier this year, the MHRA greenlighted Phase I trials based on positive preclinical results that suggested benefits in gastrointestinal barrier function and pain alleviation.
Even though GSK has stepped back from direct involvement in developing GSK4381406, they will still receive a low-single-digit royalty on net sales if Sosei Heptares successfully brings the drug to market. The potential impact on millions of patients worldwide suffering from inflammatory bowel disease (IBD) underscores the importance of this ongoing pharmaceutical research.
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